FDA Approves Capsaicin Patch as Treatment for Diabetic Neuropathy

By Pat Anson, PNN Editor

Millions of patients with diabetic peripheral neuropathy live with burning or stinging pain in their hands and feet. In what could be called a case of fighting fire with fire, the U.S. Food and Drug Administration has approved the first use of a medicated patch made with capsaicin – the spicy substance that makes chili peppers hot – as a treatment for diabetic neuropathy.

The Qutenza skin patch is made by Grünenthal and contains 8% capsaicin, which acts on pain receptors in the skin by desensitizing and numbing nerve endings.

“Pain associated with diabetic neuropathy is an extremely challenging condition to diagnose, treat and manage effectively, which has a significant quality of life impact for many patients,” said David Simpson, MD, a Professor of Neurology at the Icahn School of Medicine. “In addition, patients are dissatisfied with unresolved pain and the side effects associated with current systemic treatments.”

A 2015 study found that Qutenza worked faster than pregabalin (Lyrica) in treating neuropathic pain, providing relief in 7.5 days, compared to an average of 36 days in patients taking pregabalin. Patients who used Qutenza were also more satisfied with their treatment and had fewer side effects.

That same year the European Commission approved Qutenza as a treatment for diabetic neuropathy, but it took another five years for the FDA to give its approval for the same condition. The patch was initially approved by the FDA in 2009 for treating post-herpetic neuralgia, a complication from shingles.

“Painful diabetic peripheral neuropathy has a significant impact on the day-to-day lives of millions of individuals, and we believe Qutenza can be a much-needed non-opioid treatment option for these patients,” Jan Adams, Grünenthal’s Chief Scientific Officer, said in a statement. “This expanded indication of Qutenza in the U.S. is an exciting milestone in our efforts to make Qutenza available to even more patients in need worldwide.”  

A big catch is that the patch shouldn’t be applied at home and should only be used sparingly. According to its warning label, Qutenza should be applied by a doctor or healthcare professional, who should be wearing a face mask and gloves to protect themselves in a well-ventilated area. Up to four patches can be applied on the feet for up to 30 minutes, a procedure that can be repeated every three months. The most common side effects are redness, itching and irritation of the skin where the patch is applied.

Qutenza has gotten mixed reviews from patients, who warned that capsaicin can cause painful burning sensations.

“Qutenza really does work. I did have very intense burning,” a patient posted in a review on Drugs.com. “The pain can be mind blowing but it does subside and a cool fan helps. Don't let your pets near the area as it will burn them. I have had multiple Qutenza and… it lasts up to 3 months plus. Don't apply yourselves. Use a health professional as it does burn.”

“Although I was informed about this treatment and how your body might react to it, my case spiraled out of hands,” another patient wrote. “The medics had to call a team to manage my situation. The pain was so much that without a shred of doubt words simply can not explain.”

Diabetic neuropathy is a progressive and debilitating complication of diabetes that affects more than 5 million Americans. Patients typically experience numbness, tingling or stabbing sensations in their hands and feet. More severe cases can result in foot ulcers, amputations and other complications.

Stem Cell Therapy for Lower Back Pain Moves Closer

By A. Rahman Ford, PNN Columnist

There’s good news on the horizon for those who suffer from lower back pain due to disc degeneration.

Mesoblast, an Australian biotech company, has partnered with Grunenthal, a large German pharmaceutical company, to commercialize an investigational stem cell product called MPC-06-ID -- a stem cell formula comprised of mesenchymal cells derived from the bone marrow of healthy volunteers. Mesoblast could receive up to $1 billion from Grunenthal if the treatment is successful.

MPC-06-ID is currently in a Phase III placebo-controlled trial in the U.S. In the trial, millions of stem cells grown in a laboratory are injected into the patients’ degenerated discs with the goal of reducing inflammation and causing the discs to regenerate.

In previous trials, 47% of those who received the injection had a significant reduction in pain 12 months later. The results persisted for three years.

The estimated study completion date for the Phase III trial is March 2021. So, unfortunately, there is a bit of a wait. But Mesoblast is hopeful the study findings will result in FDA approval.

The company is also studying a stem cell product for chronic lower back pain. More on Mesoblast’s products and how they treat back pain can be found here.

What does this mean? First and foremost, it’s great news for people suffering from back pain. This is a population that is woefully underserved by conventional medicine. Limited options include analgesics like opioids, which are increasingly difficult to obtain, and spinal surgery that is costly, often ineffective and can even exacerbate the problem. I have previously written about these issues here.

Clinicians around the country have been using stem cell therapy (SCT) for years to treat back pain and even difficult spinal conditions like arachnoiditis. However, these clinics have been operating under the scythe of potential persecution for using products not approved by the FDA.

Not only has this placed them squarely in the crosshairs of regulatory authorities which issue warning letters and file lawsuits, but it has also subjected them to internet censorship by Google and others.

The Mesoblast-Grunenthal partnership is indicative of the fact that major corporate investment in SCT is increasing -- and that can be a great thing for consumer choice. More and more biotech investors are recognizing that SCT is the future of medicine, especially when it comes to treating conditions caused by chronic inflammation. Forbes reports that the market size of the SCT industry was $8.65 billion in 2018, with a projected annual growth rate of 8.8%.

We saw recent evidence of this trend with Bayer’s acquisition of Bluerock Therapeutics’ and its stem cell treatments for Parkinson’s disease and other chronic illnesses. And Boston-based Vertex Pharmaceuticals recently acquired Semma Therapeutics for $950 million in a bet that its SCT products could cure type 1 diabetes.

Why is the SCT market so robust? Transparency Market Research attributes it to a “rise in consumer awareness.” In other words, people are desperate for relief and looking for new treatments. Suffice it to say, any additional treatment option for those suffering from back pain is more than welcome.

A. Rahman Ford, PhD, is a lawyer and research professional. He is a graduate of Rutgers University and the Howard University School of Law, where he served as Editor-in-Chief of the Howard Law Journal.

Rahman lives with chronic inflammation in his digestive tract and is unable to eat solid food. He has received stem cell treatment in China. 

The information in this column is for informational purposes only and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

FDA Designates CRPS Drug as ‘Breakthrough Therapy’

By Pat Anson, Editor

The U.S. Food and Drug Administration has designated an experimental drug as a potential breakthrough therapy for Complex Regional Pain Syndrome (CRPS), a chronic and disabling neurological disease for which there is no cure or treatment.

Neridronic acid was discovered by Abiogen Pharma, an Italian drug maker, and is jointly being developed with Grünenthal, a German pharmaceutical company.

The Breakthrough Therapy designation by the FDA came after the companies reported the results of a Phase II clinical trial showing a significant reduction in pain and symptoms of CRPS with neridronic acid treatment. The drug has already received fast track and orphan drug designations from the FDA.

The agency considers a new drug as a breakthrough therapy if it is intended to treat a serious condition and if preliminary clinical evidence demonstrates substantial improvement over current treatments. There are no current FDA approved treatments for CRPS, which is also known as Reflex Sympathetic Dystrophy (RSD).

"It is very encouraging to see that the FDA recognizes the urgent need for new treatments for patients with CRPS and has granted neridronic acid the status of a Breakthrough Therapy. This supports our efforts to develop an efficacious treatment option to these patients,” said Klaus-Dieter Langner, MD, Chief Scientific Officer of Grünenthal. “We are committed to working closely with the FDA to bring neridronic acid to patients with CRPS as fast as possible.”

In the Phase II study, neridronic acid or a placebo was administered intravenously to 464 patients with CRPS type 1, when the disease is in its early stages. The study ended in November.  

A previous study of 82 CRPS patients in Italy found that those who were treated with infusions of neridronic acid experienced significant and persistent reductions in pain.

Neridronic acid is currently being evaluated in a Phase III clinical trial. If successful, the drug could be the first FDA-approved treatment for CRPS, which is characterized by severe, burning pain that usually begins in the arms or legs after an injury or surgery. The pain often spreads throughout the body.

"Grünenthal is highly dedicated to improving the lives of patients with pain as well as rare diseases with limited treatment options. This is an area of high unmet medical need,” Gabriel Baertschi, CEO of the Grünenthal.

The company recently purchased Thar Pharmaceuticals, which is developing an oral form of zoledronic acid for the treatment of CRPS. That drug is also undergoing a Phase III study.

Neridronic acid is an investigational aminobisphosphonate. According to the Reflex Sympathetic Dystrophy Syndrome Association (RSDSA), bisphosphonates have been used for years overseas to treat CRPS.

“We need options and if this can help patients and encourage other medications and treatment options to come onto the market for CRPS’ers, it’s a great thing,” said Barby Ingle, who suffers from CRPS/RSD and is President of the International Pain Foundation.

“We saw with fibromyalgia and Lyrica that once it (fibromyalgia) had a medication designated it gained more awareness and acceptance in society, leading to better access to care. The same could happen with a CRPS designation for a medication, leading to greater treatments and a cure in the future.”

What Does Your Pain Feel Like?

By Pat Anson, Editor

Does your chronic pain feel like you’ve been hit with a hammer, a bad sunburn that won’t go away, or ants crawling under your skin?

Those are some of the choices patients have in a new campaign launched in Ireland to change the way patients describepain to their physicians.   

Accurately assessing pain is difficult because pain is so subjective. For many years doctors have relied on various versions of the Wong Baker Pain Scale – a series of sad and smiling faces a patient chooses from to help their doctor understand how much pain they are in. The scale is so simple it was originally developed for children, but is now used around the world for adults.

The “Mypainfeelslike…” campaign aims to improve on that method by using more descriptive images and phrases to help doctors understand and diagnose their patient’s pain. The campaign focuses on neuropathic pain, but can be used for many other types of chronic pain. The initiative is sponsored by Grunenthal Group, a German pharmaceutical company.

Instead of an unhappy face, patients can choose from a dozen images, ranging from a burning flame to a rope tied in knots to a set of ice cubes. They also fill out a questionnaire and select different phrases to describe their pain, such as “a hot iron on my skin” or “a volcano erupting.”

Patients are also asked to fill out a questionnaire to select different phrases to describe their pain, such as “a hot iron on my skin” or “a volcano erupting.” And there's a list of multiple choice answers to describe how pain affects their ability to work, exercise and socialize.

It may take a few minutes to complete the questionnaire, but the idea is to get patients to “invest more time and accurateness in thinking about their symptoms, describing them more precisely, and preparing for doctors’ appointments.”

“Doing so forces us to reconsider our chronic pain, and the different ways that we feel it. This improves our self-awareness, allows us to better communicate our situation, and helps us get the most value out of the very short time that we usually have during doctors’ appointments,” the website says.

To take the questionnaire, click here.

According to a survey by Grunenthal, over half of Irish pain sufferers feel frustrated when trying to communicate their pain to a doctor. Over a quarter say they delay discussing their pain because they’re not sure how to do it.

“Living with chronic or nerve pain affects people’s well-being, their ability to be independent, their productivity and relationships, which can lead to feelings of depression," John Lindsay, chair of Chronic Pain Ireland told the Irish Independent.  “The ‘Mypainfeelslike…’ campaign will help raise awareness of the impact of chronic pain and give people living with this disease the tools to re-evaluate their pain management plans.”